SB 206-1_ Filed 04/27/2005, 11:30
Adopted 4/27/2005
CONFERENCE COMMITTEE REPORT
DIGEST FOR ESB 206
Citations Affected: IC 25-26-21.
Synopsis: Home medical equipment services providers. Conference committee report for ESB
206. Requires a home medical equipment services provider to be licensed by the board of
pharmacy. Authorizes the board to conduct inspections, issue licenses, discipline providers for
violations, and adopt rules to: (1) specify the equipment to be regulated; (2) set standards for the
licensure of services providers; (3) govern the safety and quality of services that are provided;
and (4) set reasonable fees for the application, issuance, and renewal of a license. Makes
conforming changes. (This conference committee report: (1) removes provisions concerning
home health agencies and personal service agencies; and (2) provisions concerning
temporary licenses.)
Effective: July 1, 2005.
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Adopted Rejected
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CONFERENCE COMMITTEE REPORT
MR. SPEAKER:
Your Conference Committee appointed to confer with a like committee from the Senate
upon Engrossed House Amendments to Engrossed Senate Bill No. 206 respectfully reports
that said two committees have conferred and agreed as follows to wit:
that the Senate recede from its dissent from all House amendments and that
the Senate now concur in all House amendments to the bill and that the bill
be further amended as follows:
Delete everything after the enacting clause and insert the following:
SOURCE: IC 25-26-21; (05)CC020601.1. -->
SECTION 1. IC 25-26-21 IS ADDED TO THE INDIANA CODE
AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2005]:
Chapter 21. Home Medical Equipment Services Providers
Sec. 1. As used in this chapter, "board" refers to the Indiana
board of pharmacy established by IC 25-26-13-3.
Sec. 2. As used in this chapter, "home medical equipment" means
technologically sophisticated medical devices that may be used in
a residence, including the following:
(1) Oxygen and oxygen delivery systems.
(2) Ventilators.
(3) Respiratory disease management devices.
(4) Continuous positive airway pressure (CPAP) devices.
(5) Electronic and computerized wheelchairs and seating
systems.
(6) Apnea monitors.
(7) Transcutaneous electrical nerve stimulator (TENS) units.
(8) Low air loss cutaneous pressure management devices.
(9) Sequential compression devices.
(10) Feeding pumps.
(11) Home phototherapy devices.
(12) Infusion delivery devices.
(13) Distribution of medical gases to end users for human
consumption.
(14) Hospital beds.
(15) Nebulizers.
(16) Other similar equipment determined by the board in rules
adopted under section 7 of this chapter.
Sec. 3. As used in this chapter, "home medical equipment
services" means the:
(1) sale;
(2) rental;
(3) delivery;
(4) installation;
(5) maintenance or replacement; or
(6) instruction in the use;
of medical equipment used by an individual that allows the
individual to reside in a noninstitutional environment.
Sec. 4. As used in this chapter, "provider" means a person
engaged in the business of providing home medical equipment
services to an unrelated individual in the individual's residence.
Sec. 5. (a) This chapter does not apply to the following:
(1) A home health agency (as defined in IC 16-27-1-2) that does
not sell, lease, or rent home medical equipment.
(2) A hospital licensed under IC 16-21-2 that:
(A) provides home medical equipment services only as an
integral part of patient care; and
(B) does not provide home medical equipment services
through a separate business entity.
(3) A manufacturer or wholesale distributor that does not sell,
lease, or rent home medical equipment directly to a consumer.
(4) Except as provided under subsection (b), a practitioner (as
defined in IC 25-1-9-2) who does not sell, lease, or rent home
medical equipment.
(5) A veterinarian licensed under IC 15-5-1.1.
(6) A hospice program (as defined in IC 16-25-1.1-4) that does
not sell, lease, or rent home medical equipment.
(7) A health facility licensed under IC 16-28 that does not sell,
lease, or rent home medical equipment.
(8) A provider that:
(A) provides home medical equipment services within the
scope of the licensed provider's professional practice;
(B) is otherwise licensed by the state; and
(C) receives annual continuing education that is documented
by the provider or the licensing entity.
(9) An employee of a person licensed under this chapter.
(b) A pharmacist licensed in Indiana or a pharmacy that holds a
permit issued under IC 25-26 that sells, leases, or rents home
medical equipment:
(1) is not required to obtain a license under this chapter; and
(2) is otherwise subject to the:
(A) requirements of this chapter; and
(B) requirements established by the board by rule under this
chapter.
Sec. 6. (a) A person seeking to provide home medical equipment
services in Indiana shall apply to the board for a license in the
manner prescribed by the board.
(b) A provider shall do the following:
(1) Comply with:
(A) federal and state law; and
(B) regulatory requirements;
for home medical equipment services.
(2) Maintain a physical facility and medical equipment
inventory in Indiana.
(3) Purchase and maintain in an amount determined by the
board:
(A) product liability insurance; and
(B) professional liability insurance;
and maintain proof of the insurance coverage.
(4) Establish procedures to ensure that an employee or a
contractor of the provider who is engaged in the following
home medical equipment activities receives annual training:
(A) Delivery.
(B) Orientation of a patient in the use of home medical
equipment.
(C) Reimbursement assistance.
(D) Maintenance.
(E) Repair.
(F) Cleaning and inventory control.
(G) Administration of home medical equipment services.
The provider shall maintain documentation of the annual
training received by each employee or contractor.
(5) Maintain clinical records on a customer receiving home
medical equipment services.
(6) Establish home medical equipment maintenance and
personnel policies.
(7) Provide home medical equipment emergency maintenance
services available twenty-four (24) hours a day.
(8) Comply with the rules adopted by the board under this
chapter.
Sec. 7. (a) The board may adopt rules under IC 4-22-2 to do the
following:
(1) Specify home medical equipment in addition to the home
medical equipment set forth in section 2 of this chapter that is
to be regulated under this chapter.
(2) Set standards for the licensure of providers.
(3) Govern the safety and quality of home medical equipment
services that are provided to customers.
(4) Specify the amount of insurance coverage required under
section 6(b)(3) of this chapter.
(5) Set reasonable fees for the application, issuance, and
renewal of a license under this chapter and set other fees
permitted under IC 25-1-8.
(b) The board may consult with individuals engaged in the home
medical equipment services business to advise the board on the
formulation of rules under subsection (a). The individuals may not
be compensated or reimbursed for mileage by the board.
Sec. 8. (a) After June 30, 2006, a provider must be licensed by the
board before the provider may provide home medical equipment
services. If a provider provides home medical equipment services
from more than one (1) location in Indiana, the provider must
obtain a license under this chapter for each location.
(b) An applicant shall submit the application to the board on a
form adopted by the board. The nonrefundable application fee set
by the board must be submitted with the application. The fee must
be deposited in the state general fund.
(c) If the board determines that the applicant:
(1) meets the standards set forth by the board; and
(2) has satisfied the requirements under this chapter and the
requirements established by the board by rule;
the board shall notify the applicant in writing that the license is
being issued to the applicant. The license is effective on the
applicant's receipt of the written notification.
(d) A license issued under this chapter is effective for not more
than two (2) years, beginning on a date determined by the board.
An entity that is licensed under this chapter shall display the license
or a copy of the license on the licensed premises.
(e) The board may renew a license every two (2) years.
Sec. 9. (a) The board may inspect the operations and facilities of
an applicant for a license under this chapter to determine whether
to issue the applicant a license.
(b) The board may conduct random inspections at any time for
the following reasons:
(1) To ensure the integrity and effectiveness of the licensing
process.
(2) To investigate a consumer complaint or a complaint by a
qualified source as identified by the board.
(3) To ensure continuing compliance with the licensing
requirements under this chapter.
(c) The board shall provide the provider a report of the board's
findings after the board completes an investigation under this
section.
(d) A provider that disputes the report in subsection (c) may file
an appeal under IC 4-21.5 with the board not later than thirty (30)
days after receipt of the report. The board shall review the
inspection report and, upon the provider's request, conduct a new
inspection.
(e) The board shall employ qualified inspectors to investigate
complaints and conduct inspections. Investigators may review and
audit records under an investigation or inspection during the
inspected facility's normal business hours at the place of business
of the provider being investigated.
(f) The board and the board's employees may not disclose
confidential information obtained during an investigation except:
(1) during a disciplinary hearing held under section 10 of this
chapter; or
(2) under a court order.
Sec. 10. The board may discipline the holder of a license under
IC 25-1-9 after a hearing or for any of the following reasons:
(1) Violation of this chapter or violation of a rule established by
the board.
(2) Violation of a board order.
(3) Failure to meet the standards set forth in section 6(b) of this
chapter.
(4) The conviction or plea of guilty for a felony or misdemeanor
that:
(A) involves fraud or deceit; or
(B) is directly related to providing home medical equipment
services.
(5) Negligence or gross misconduct in providing home medical
equipment services.
(6) The aid, assistance, or willful allowance of another person
in violating a provision under this chapter or a rule adopted by
the board.
(7) Failure to provide information within sixty (60) days in
response to a written request from the board.
(8) The engagement in conduct that is likely to deceive,
defraud, or harm the public.
(9) Denial, revocation, suspension, or restriction of a license in
another state or jurisdiction to provide home medical
equipment services for a reason other than the failure to renew
the license.
(10) The receipt of a fee, commission, rebate, or other form of
compensation for services not rendered.
(11) Knowingly making or filing false records, reports, or
billings in the course of providing home medical equipment
services, including false records, reports, or billings prepared
for or submitted to state or federal agencies or departments.
(12) Failure to comply with federal rules issued under the
federal Medicare program (42 U.S.C. 1395 et seq.) relating to
operations, financial transactions, and general business
practices of home medical equipment services providers.
Sec. 11. (a) A person who engages in the business of home
medical equipment services and who:
(1) is required to be licensed under this chapter; and
(2) knowingly provides home medical equipment services
without a license issued under this chapter;
commits a Class A misdemeanor.
(b) Each day a violation of this section continues constitutes a
separate offense.
(c) The board may, in the name of the state and through the
attorney general, apply in a court to enjoin a person from
providing home medical equipment services in violation of this
chapter.
(Reference is to ESB 206 as printed March 18, 2005.)
Conference Committee Report
on
Engrossed Senate Bill 206
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S
igned by:
____________________________ ____________________________
Senator DillonRepresentative Lehe
Chairperson
____________________________ ____________________________
Senator BreauxRepresentative Reske
Senate Conferees House Conferees